Jørgensen Stian Langgård, Bohn Marie Bagger, Aagaard Per, Mechlenburg Inger
Department of Occupantional and Physical Therapy, Horsens Regional Hospital, Horsens, Denmark
H-HIP, Horsens Regional Hospital, Horsens, Denmark.
BMJ Open. 2020 Oct 1;10(10):e034376. doi: 10.1136/bmjopen-2019-034376.
Up to 20% of patients undergoing total knee replacement (TKR) surgery report no or suboptimal pain relief after TKR. Moreover, despite chances of recovering to preoperative functional levels, patients receiving TKR have demonstrated persistent deficits in quadriceps strength and functional performance compared with healthy age-matched adults. We intend to examine if low-load blood flow restricted exercise (BFRE) is an effective preoperative method to increase functional capacity, lower limb muscle strength and self-reported outcomes after TKR. In addition, the study aims to investigate to which extent preoperative BFRE will protect against surgery-related atrophy 3 months after TKR.
In this multicentre, randomised controlled and assessor blinded trial, 84 patients scheduled for TKR will be randomised to receive usual care and 8 weeks of preoperative BFRE or to follow usual care-only. Data will be collected before randomisation, 3-4 days prior to TKR, 6 weeks, 3 months and 12 months after TKR. Primary outcome will be the change in 30 s chair stand test from baseline to 3-month follow-up. Key secondary outcomes will be timed up and go, 40 me fast-paced walk test, isometric knee extensor and flexor strength, patient-reported outcome and selected myofiber properties.Intention-to-treat principle and per-protocol analyses will be conducted. A one-way analysis of variance model will be used to analyse between group mean changes. Preintervention-to-postintervention comparisons will be analysed using a mixed linear model. Also, paired Student's t-test will be performed to gain insight into the potential pretraining-to-post-training differences within the respective training or control groups and regression analysis will be used for analysation of associations between selected outcomes.
The trial has been accepted by the Central Denmark Region Committee on Biomedical Research Ethics (Journal No 10-72-19-19) and the Danish Data Protection Agency (Journal No 652164). All results will be published in international peer-reviewed scientific journals regardless of positive, negative or inconclusive results.
NCT04081493.
高达20%接受全膝关节置换术（TKR）的患者在术后报告疼痛缓解不明显或效果欠佳。此外，尽管有恢复到术前功能水平的机会，但与年龄匹配的健康成年人相比，接受TKR的患者在股四头肌力量和功能表现方面仍存在持续缺陷。我们打算研究低负荷血流限制运动（BFRE）是否是一种有效的术前方法，以提高TKR术后的功能能力、下肢肌肉力量和自我报告的结果。此外，该研究旨在调查术前BFRE在多大程度上能预防TKR术后3个月与手术相关的萎缩。
在这项多中心、随机对照且评估者盲法的试验中，84名计划接受TKR的患者将被随机分为两组，一组接受常规护理和8周的术前BFRE，另一组仅接受常规护理。数据将在随机分组前、TKR术前3 - 4天、TKR术后6周、3个月和12个月收集。主要结局将是从基线到3个月随访期间30秒坐立试验的变化。关键次要结局将是计时起立行走测试、40米快速步行测试、等长膝关节伸肌和屈肌力量、患者报告的结局以及选定的肌纤维特性。将进行意向性分析原则和符合方案分析。将使用单因素方差分析模型分析组间平均变化。干预前与干预后的比较将使用混合线性模型进行分析。此外，将进行配对学生t检验，以了解各自训练组或对照组内潜在的训练前与训练后差异，并将使用回归分析来分析选定结局之间的关联。
该试验已获得丹麦中部地区生物医学研究伦理委员会（期刊编号10 - 72 - 19 - 19）和丹麦数据保护局（期刊编号652164）的批准。无论结果是阳性、阴性还是不确定，所有结果都将发表在国际同行评审的科学期刊上。
NCT04081493。
